Double-blind, Randomized placebo controlled trial of fulvestrant compared with exemestane after prior nonsteroidal aromatase inhibitor therapy in postmenopausal women with hormone receptor-positive, advanced breast cancer: Results from EFECT

Purpose The third-generation nonsteroidal aromatase inhibitors (AIs) are increasingly used as adjuvant and first-line advanced therapy for postmenopausal, hormone receptor-positive (HR +) breast cancer. Because many patients subsequently experience progression or relapse, it is important to identify agents with efficacy after AI failure. Materials and Methods Evaluation of Faslodex versus Exemestane Clinical Trial (EFECT) is a randomized, double-blind, placebo controlled, multicenter phase III trial of fulvestrant versus exemestane in postmenopausal women with HR + advanced breast cancer (ABC) progressing or recurring after nonsteroidal AI. The primary end point was time to progression (TTP). A fulvestrant loading-dose (LD) regimen was used: 500 mg intramuscularly on day 0, 250 mg on days 14, 28, and 250 mg every 28 days thereafter. Exemestane 25 mg orally was administered once daily. Results A total of 693 women were randomly assigned to fulvestrant (n = 351) or exemestane ( n = 342). Approximately 60% of patients had received at least two prior endocrine therapies. Median TTP was 3.7 months in both groups ( hazard ratio = 0.963; 95% CI, 0.819 to 1.133; P = .6531). The overall response rate ( 7.4% v 6.7%; P = .736) and clinical benefit rate ( 32.2% v 31.5%; P = .853) were similar between fulvestrant and exemestane respectively. Median duration of clinical benefit was 9.3 and 8.3 months, respectively. Both treatments were well tolerated, with no significant differences in the incidence of adverse events or quality of life. Pharmacokinetic data confirm that steady-state was reached within 1 month with the LD schedule of fulvestrant. Conclusion Fulvestrant LD and exemestane are equally active and well-tolerated in a meaningful proportion of postmenopausal women with ABC who have experienced progression or recurrence during treatment with a nonsteroidal AI.

Asthma mortality in Australia 1920-94: Age, period, and cohort effects

Study objective-To investigate asthma mortality during 1920-94 in Australia in order to assess the relative role of period and birth cohort effects. Design-Asthma mortality (both sexes) was age standardised and examined for changes over time. The data were also examined for age, period, and cohort (APC) effects using Poisson regression modelling. Setting-National Australian mortality data. Participants-Population (both sexes) aged 15-34 years, 1920-94. Main results-Age adjusted period rates indicate an increase in asthma mortality during the 1950s, and increases and subsequent falls (epidemics) during the mid 1960s and late 1980s. APC modelling suggested an increasing cohort effect (adjusted for both age and period) from the birth cohort 1950-54 onwards. Period effects (adjusted for age and cohort) are characterised by an increase in the 1950s (possibly due to changes in diagnostic labelling), minimal or no increases in the mid 1960s and late 1980s (where period peaks had been noted when data were adjusted for age only), and declines in mortality risk subsequent to the periods where age-period analysis had noted increases. Thus, in Australia, some of the mid 1960s epidemic in asthma deaths, and all of the late 1980s mortality increase, seem to be attributable to cohort effects. Conclusions-The increase in asthma mortality cohort effect is consistent with empirical evidence of recent increases in prevalence (and presumably incidence) of asthma in Australia, and suggests the need for more research into the underlying environmental aetiology of this condition.

Relationship between use of technology and employment rates for people with physical disabilities in Australia: Implications for education and training programmes

This study examined the impact of computer and assistive device use on the employment status and vocational modes of people with physical disabilities in Australia. A survey was distributed to people over 15 years in age with physical disabilities living in the Brisbane area. Responses were received from 82 people, including those with spinal cord injuries, cerebral palsy and muscular dystrophy. Of respondents 46 were employed, 22 were unemployed, and 12 were either students or undertaking voluntary work. Three-quarters of respondents used a computer in their occupations, while 15 used assistive devices. Using logistic regression analysis it was found that gender, education, level of computer skill and computer training were significant predictors of employment outcomes. Neither the age of respondent nor use of assistive software were significant predictors. From information obtained in this study guidelines for a training programme designed to maximize the employability of people with physical disabilities were developed.

Consumption of fruits and vegetables and C - reactive protein in women undergoing cosmetic surgery

Low-grade inflammation adversely influences metabolism and cardiovascular prognosis, nevertheless increased intake of fruits and vegetables has rarely been studied in this context. Objective: In a prospective controlled study, the effect on C-reactive protein (CRP) levels was assessed. Methodology: Sixty consecutive women undergoing cosmetic abdominal surgery were instructed to consume six servings each of fruits and vegetables during the first postoperative month. Detailed 24h interviewer-administered dietary recall was conducted at baseline and at the end of the study, with weekly returns to monitor unscheduled dietary changes and compliance with the protocol. Variance (ANOVA) and covariance (ANCOVA) were evaluated to confirm significance and minimize confounding variables. Results: No differences concerning age (42.2 +/- 5.3 vs 41.1 +/- 6.0 years) or BMI (25.5 +/- 3.1 vs 25.0 +/- 3.0 kg/m(2)) occurred. Ingestion of fruits increased to approximately 5.2 vs 3.9 and of vegetables 5.9 vs 3.4 servings/ day, respectively. CRP decreased more conspicuously in the treated group (P = 0.028), and correlation between vitamin C input and CRP in supplemented participants was demonstrated (P = 0.014). Conclusions: Higher intake of antioxidant foods was feasible, and an antiinflammaotory effect occurred. Further studies with longer administration and follow-up period are recommended.

Improving wheat simulation capabilities in Australia from a cropping systems perspective: water and nitrogen effects on spring wheat in a semi-arid environment

Systems approaches can help to evaluate and improve the agronomic and economic viability of nitrogen application in the frequently water-limited environments. This requires a sound understanding of crop physiological processes and well tested simulation models. Thus, this experiment on spring wheat aimed to better quantify water x nitrogen effects on wheat by deriving some key crop physiological parameters that have proven useful in simulating crop growth. For spring wheat grown in Northern Australia under four levels of nitrogen (0 to 360 kg N ha(-1)) and either entirely on stored soil moisture or under full irrigation, kernel yields ranged from 343 to 719 g m(-2). Yield increases were strongly associated with increases in kernel number (9150-19950 kernels m(-2)), indicating the sensitivity of this parameter to water and N availability. Total water extraction under a rain shelter was 240 mm with a maximum extraction depth of 1.5 m. A substantial amount of mineral nitrogen available deep in the profile (below 0.9 m) was taken up by the crop. This was the source of nitrogen uptake observed after anthesis. Under dry conditions this late uptake accounted for approximately 50% of total nitrogen uptake and resulted in high (>2%) kernel nitrogen percentages even when no nitrogen was applied,Anthesis LAI values under sub-optimal water supply were reduced by 63% and under sub-optimal nitrogen supply by 50%. Radiation use efficiency (RUE) based on total incident short-wave radiation was 1.34 g MJ(-1) and did not differ among treatments. The conservative nature of RUE was the result of the crop reducing leaf area rather than leaf nitrogen content (which would have affected photosynthetic activity) under these moderate levels of nitrogen limitation. The transpiration efficiency coefficient was also conservative and averaged 4.7 Pa in the dry treatments. Kernel nitrogen percentage varied from 2.08 to 2.42%. The study provides a data set and a basis to consider ways to improve simulation capabilities of water and nitrogen effects on spring wheat. (C) 1997 Elsevier Science B.V.

Resting energy expenditure in white and non-white severely obese women

This study aimed to compare the resting energy expenditure (REE) of white and non-white severely obese Brazilian women. REE was examined in 83 severely obese Brazilian women (n = 58 white and 25 non-white) with mean (+/- SD) age 42.99 +/- 11.35 and body mass index 46.88 +/- 6.22 kg/m(2) who were candidates for gastric bypass surgery. Body composition was assessed by air displacement plethysmography (ADP) BOD PODO body composition system (Life Measurement Instruments, Concord, CA) and REE was measured, under established protocol, with an open-circuit calorimeter (Deltatrac II MBM-200, Datex-Ohmeda, Madison, WI, USA). There was no significant difference between the REE of white and non-white severely obese women (1,953 +/- 273 and 1,906 +/- 271 kcal/d, respectively; p = 0.48). However, when adjusted for fat free mass (MLG), REE was significantly higher in non-white severely obese women (difference between groups of 158.4 kcal, p < 0.01). REE in white women was positively and significantly correlated to C-reactive protein (PCR) (r = 0.41.8; P < 0.001) and MLG (r = 0.771; P < 0.001). In the non-white women, REE was only significantly correlated to MLG (r = 0.753; P < 0.001). The multiple linear regression analysis showed that skin color, MLG and PCR were the significant determinants of REE (R(2) = 0.55). This study showed that, after adjustment for MLG, non-white severely obese women have a higher REE than the white ones. The association of body composition inflammation factors and REE in severely obese Brazilian women remains to be further investigated.

Follow-up of Pregnant Women With Autoimmune Hepatitis The Disease Behavior Along With Maternal and Fetal Outcomes

Goals: To assess maternal and fetal outcomes and clinical management of pregnancy in patients with autoimmune hepatitis (AIH). Background: There is a paucity of information about maternal and fetal outcomes, and AIH activity during pregnancy and in the postpartum period. There is no consensus about the administration of azathioprine during pregnancy and breastfeeding. Study: Retrospective analysis of 54 pregnancies (3 still in progress) in 39 AIH patients. Results: The median age at conception was 24 years, and 68.4% of women had liver cirrhosis. Before conception and in early pregnancy, azathioprine and prednisone were administered in 48.1%, but treatment regimen vas usually changed further to 20 mg/d prednisone and 20.4%, were off treatment. There were 36 livebirths, and fetal loss rates were 29.4% (13 miscarriages, 1 stillbirth, and 1 ectopic pregnancy). Preterm birth rate was 11.8%. In 2 cases, there was acute fetal distress; and in 2 others congenital malformations (3.9%). The rate of serious maternal complication was 7.8%, with no deaths. There were no flares in 41.2% pregnancies, but aminotransferase elevations occurred in 54.9%, 31.4% of which were true AIH relapses, only registered in the postpartum period. Conclusions: Despite the high fetal miscarriage rate, pregnancy in AIH was safe. Patients needed careful monitoring, especially in the postpartum period because of relapses. There was no evidence of a cause and effect relationship among azathioprine administration and premature births and congenital abnormalities, but more studies are necessary. Higher doses of prednisone may be an alternative option for those who prefer azathioprine withdrawal during pregnancy.

Out of the shadows: The critical sociology of sport in Australia, 1986 to 1996

The sociology of sport in Australia has reached a key point in its development. A critical tradition in the subdiscipline has been established over the last decade, but its intellectual and institutional progress has been uneven. This article briefly traces the emergence of critical sports sociology in a country outside the major centers in the UK and U.S., its break with functionalist approaches, and its attempts to overcome the neglect of local mainstream sociology. The authors proceed to examine (self-reflexively) the changes of theoretical direction and the new lines of research that are being explored in the field. A recent ''skirmish'' with narrative history over the preferred theories and methods in sports analysis is discussed as illustrative of the difficulties encountered by an energetic but small, dispersed and underorganized scholarly movement in Australia.

Gender equality and participation in housework: A cross-national perspective

This paper examines men's and women's participation in housework in the United States, Sweden, Norway, Canada and Australia. While there has been considerable research into the factors relating to the division of housework between husbands and wives within countries, very little research has examined the way in which housework patterns vary across countries. The results show that women continue to undertake the bulk of domestic labor in all five countries, and that the factors determining men's and women's participation in housework do not vary markedly across countries. This suggests that variations across countries in levels of gender equality at a broader level have only very limited effects on levels of gender equality in the home.